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Table 2 Baseline characteristics, by intervention group

From: Daily home fortification with iron as ferrous fumarate versus NaFeEDTA: a randomised, placebo-controlled, non-inferiority trial in Kenyan children

Characteristic

Placebo

Iron, 3 mg as NaFeEDTA

Iron, 12.5 mg as ferrous fumarate

Number (n)

112

112

114

General characteristics

 Sex, male

69 (61.6%)

61 (54.5%)

56 (49.1%)

 Age, months

22.8 (6.8)

23.2 (6.2)

24.9 (6.4)

 Age class

   

  12–23 months

61 (54.5%)

57 (50.9%)

44 (38.6%)

  24–36 months

51 (45.5%)

55 (49.1%)

70 (61.4%)

Nutritional markers

 Haemoglobin concentration, g/L

104.4 (13.2)

105.9 (13.3)

104.7 (13.3)

 Anaemia

  Moderate (haemoglobin concentration 70–99.99 g/L)

33 (29.5%)

34 (30.4%)

36 (31.6%)

  Mild (haemoglobin concentration 100–109.99 g/L)

39 (34.8%)

31 (27.7%)

37 (32.5%)

  No anaemia (haemoglobin concentration ≥110 g/L)

40 (35.7%)

47 (42.0%)

41 (36.0%)

 ZPP:haem ratio, μmol:mola

   

  In whole blood

170 (119; 305)

172 (102; 260)

196 (137; 283)

  In erythrocytes

130 (84; 301)

141 (76; 223)

160 (101; 246)

 Plasma ferritin concentration, μg/La,b

37.7 (17.3; 74.0)

31.4 (16.0; 56.6)

36.9 (17.6; 68.8)

 Iron statusb

  Deficient (plasma ferritin concentration <12 μg/L)

17 (15.2%)

20 (18.3%)

20 (17.9%)

  Replete (plasma ferritin concentration ≥12 μg/L in the absence of inflammation)

26 (23.2%)

32 (29.4%)

19 (17.0%)

  Uncertain (plasma ferritin concentration ≥12 μg/L in the presence of inflammation)

69 (61.6%)

57 (52.3%)

73 (65.2%)

 Iron deficiency, based on adjusted ferritin concentrationsb,c

52.7% (59/112)

57.8% (63/109)

49.1% (55/112)

 Plasma soluble transferrin receptor concentration, mg/La

2.41 (1.75; 3.46)

2.39 (1.82; 3.16)

2.60 (1.93; 3.41)

 Plasma albumin concentration, g/L

34.6 (3.9)

35.0 (3.5)

34.7 (4.1)

 Vitamin B12 concentration, pmol/L

391 (291; 557)

409 (311; 569)

401 (315; 554)

Infection and inflammation markers

 Plasma C-reactive protein concentration, mg/La

2.5 (0.7; 7.6)

2.5 (0.6; 7.8)

4.5 (1.3; 11.0)

 Plasma α 1-acid glycoprotein concentration, g/La

1.20 (0.90; 1.57)

1.08 (0.81; 1.47)

1.17 (0.97; 1.63)

 Inflammation

  Plasma C-reactive protein concentration >5 mg/L

40 (35.7%)

35 (31.3%)

53 (46.5%)

  Plasma α 1-acid glycoprotein concentration >1 g/L

71 (63.4%)

63 (56.3%)

81 (71.1%)

  Plasma C-reactive protein concentration >5 mg/L or plasma α 1-acid glycoprotein concentration >1 g/L

77 (68.8%)

65 (58%)

84 (73.7%)

 Plasmodium antigenaemia, by rapid dipstick testsd

  P. falciparum (either HRP2 or P. falciparum-specific pLDH)

39 (35.1%)

40 (36.0%)

43 (38.1%)

  Plasmodium species other than P. falciparum (pLDH specific for P. malariae, P. ovale or P. vivax)e

1 (0.9%)

2 (1.8%)

0

  Any Plasmodium species

39 (35.1%)

41 (36.9%)

43 (38.1%)

 Blood smear tests, by microscopy

   

  Asexual or sexual forms of P. falciparum

47 (41.9%)

49 (43.8%)

55 (48.2%)

  Asexual forms of both P. falciparum and human Plasmodium spp. other than P. falciparum (i.e. P. malariae, P. ovale or P. vivax)

2 (1.8)

1 (0.8)

2 (1.8)

  Asexual parasite density for P. falciparum, μ/La

757 (172; 3972)

3340 (297; 20,023)

1048 (207; 6820)

   Low (<1000 μ/L)

17 (15.2%)

9 (8.0%)

19 (16.7%)

   Medium (1000–9999 μ/L)

12 (10.7%)

8 (7.1%)

15 (13.2%)

   High (≥10,000 μ/L)

3 (2.7%)

7 (6.3%)

5 (4.4%)

  Gametocyte density, μ/La

326 (49; 732)

82 (37; 120)

1126 (57; 2679)

Anthropometric markers

 Body height, cm

80.9 (5.9)

82.1 (5.7)

82.4 (5.1)

 Body weight, kg

10.6 (1.8)

10.8 (2.0)

10.9 (1.7)

 Height-for-age z-score, SD

–1.42 (1.47)

–1.15 (1.43)

–1.43 (1.31)

 Weight-for-height z-score, SD

–0.10 (1.05)

–0.16 (1.07)

–0.14 (0.93)

 Weight-for-age z-score, SD

–0.81 (1.18)

–0.71 (1.22)

–0.86 (1.09)

 Stunted (height-for-age z-score < –2 SD)

34 (30.4%)

31 (27.7%)

37 (32.5%)

 Wasted (weight-for-height z-score < –2 SD)

3 (2.7%)

5 (4.5%)

2 (1.8%)

 Underweight (weight-for-age z-score < –2 SD)

19 (17.0%)

12 (10.7%)

15 (13.2%)

  1. Values indicate n (%), mean (SD) or amedian (25th and 75th percentiles). HRP2 histidine-rich protein-2, pLDH P. falciparum-specific lactate dehydrogenase
  2. bDue to missing values for ferritin concentrations in 5 children, n was 112, 109 and 112 for groups that received placebo, NaFeEDTA and ferrous fumarate, respectively; cbased on ferritin concentrations adjusted for inflammation by linear regression (see text)
  3. dDue to missing values in 3 children, n was 111, 111 and 113 for groups that received placebo, NaFeEDTA and ferrous fumarate, respectively
  4. eOne child in placebo group and 1 child in NaFeEDTA group with antigenaemia due to P. malariae or P. ovale or P. vivax also had antigenaemia to P. falciparum (mixed infection)